MAUDE Adverse Event Report: DUTCH OPTHALMIC RESEARCH CENTER BV EVA, COMBINED MACHINE INCLUDING LASER (DORC CONNECTOR)

Model Number	8000.COM02
Medical Device Problem Code	Device Operational Issue (2914)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/19/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation determined several defective parts inside the pump module.Our r&d department is currently trying to resolve these issues.This occurred during phaco procedure.There was an error in the pump module, there is no replacement, hence considered reportable.Also prolonged delay.This reportable event was identified during a voluntary retrospective review of all complaints since 2015 by the manufacturer (dutch ophthalmic research centre (b)(4).).All available information has been disclosed.This complaint has now been closed.
Event or Problem Description
Pump error car1600 ( servo error pump actuator ) occurs during phaco.It follows after each other.Sample available.All information available has been disclosed.

• Brand Name: EVA, COMBINED MACHINE INCLUDING LASER (DORC CONNECTOR)
• Common Device Name: EVA, COMBINED MACHINE INCLUDING LASER (DORC CONNECTOR)
• Manufacturer (Section D): DUTCH OPTHALMIC RESEARCH CENTER BV; scheijdelveweg 2; zuidland, 3214V N; NL 3214VN
• MDR Report Key: 7516818
• Report Number: 1222074-2018-00133
• Device Sequence Number: 13835039
• Product Code: HQC
• UDI-Device Identifier: 08717872019659
• UDI-Public: 08717872019659
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K142877
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Model Number: 8000.COM02
• Device Catalogue Number: 8000.COM02
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2015
• Initial Report FDA Received Date: 05/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1